Please bookmark this page as I will continually update this information as additional EUA's are issued and new commercial diagnostic and serology kits are validated. All information provided in this blog are obtained from FDA's In Vitro Diagnostic EUA and FAQs on Testing for SARS-CoV-2 pages.
In vitro (IVD) devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases. There are several types of SARS-CoV-2 and COVID-19 related IVDs:
Diagnostic Tests - Tests that detect parts of the SARS-CoV-2 virus and can be used to diagnose infection with the SARS-CoV-2 virus. These include molecular tests and antigen tests.
Serology/Antibody Tests - Tests that detect antibodies (e.g., IgM, IgG) to the SARS-CoV-2 virus. Serology/antibody tests cannot be used to diagnose a current infection.
Tests for Management of COVID-19 Patients - Beyond tests that diagnose or detect SARS-CoV-2 virus or antibodies, there are also tests that are authorized for use in the management of patients with COVID-19, such as to detect biomarkers related to inflammation. Once patients are diagnosed with COVID-19 disease, these additional tests can be used to inform patient management decisions.
Numerous COVID-19 in-vitro diagnostic devices have been submitted to FDA for Emergency Use Authorizations (EUA). The following table provides an up-to-date summary of all FDA EUA's. NOTE: the table should be viewed in landscape mode on smaller handheld devices.
There are also a number of SARS-CoV-2 diagnostic and serology tests that are in development or that have been distributed while manufacturers prepare an EUA submission for a test whose performance characteristics have already been validated. Laboratories are also offering serology tests. Current lists of diagnostic and serology tests that fit into these categories are provided after the EUA table.
For more information on serology test performance, including sensitivity (true positive rate) and specificity (true negative rate), visit FDA's EUA Authorized Serology Test Performance page.
Date of EUA Original Issue
|
Entity
|
Letter of Authorization
|
Attributes3
|
Authorized Settings1
|
Authorization Documents2
| |
12/31/2020
|
Nirmidas Biotech, Inc.
|
IgM and IgG, lateral flow
|
H, M, W
| |||
12/23/2020
|
Cepheid
|
Real-time RT-PCR, Pooling
|
H, M, W
| |||
12/23/2020
|
Quanterix Corporation
|
IgG, Para-magnetic Microbead-based Sandwich ELISA, Semi-quantitative
|
H, M
| |||
12/23/2020
|
Quidel Corporation
|
Isothermal Reverse Tran-scriptase – Helicase-Dependent Amplification (RT-HDA)
|
H, M
| |||
12/18/2020
|
Quidel Corporation
|
Lateral Flow, Visual Read
|
H, M, W
| |||
12/18/2020
|
Siemens Healthcare Diagnostics Inc.
|
One-step Direct Chemilumin-escent Immuno-assay
|
H, M
| |||
12/17/2020
|
Materials and Machines Corporation of America (DBA MatmaCorp, Inc.)
|
RT-PCR and isothermal nucleic acid amplification
|
H
| |||
12/17/2020
|
Hologic, Inc.
|
Real-time TMA, Chemilumin-escent, Multi-analyte
|
H
| |||
12/16/2020
|
Abbott Diagnostics Scarborough, Inc.
|
Lateral Flow, Visual Read, Prescription Home Testing
| ||||
12/15/2020
|
ACON Laboratories, Inc.
|
IgM and IgG, Lateral Flow
|
H, M
| |||
12/15/2020
|
Ellume Limited
|
Lateral Flow, Fluore-scence, Instrument Read, Over the Counter
| ||||
12/15/2020
|
RCA Laboratory Services LLC dba GENETWORx
|
Real-time RT-PCR, Home Collection
|
H
| |||
12/11/2020
|
ResearchDx, Inc., DBA Pacific Diagnostics
|
TMA, Chemilumin-escent, Home Collection
|
H
| |||
12/09/2020
|
Laboratory Corporation of America (LabCorp)
|
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening
|
H
| |||
12/07/2020
|
Luminostics, Inc.
|
Lateral flow immuno-luminescent assay, instrument read
|
H, M, W
| |||
12/04/2020
|
Quest Diagnostics Infectious Disease, Inc.
|
Real-time RT-PCR, Multi-analyte, Home Collection
|
H
| |||
11/27/2020
|
Cepheid
|
Real-time RT-PCR
|
H, M
| |||
11/25/2020
|
Roche Diagnostics, Inc.
|
Total Antibody, ECLIA, Semi-quantitative
|
H, M
| |||
11/24/2020
|
Kantaro Biosciences, LLC
|
IgG, ELISA, Semi-quantitative
|
H
| |||
11/23/2020
|
Innovita (Tangshan) Biological Technology Co., Ltd.
|
IgM and IgG, Lateral Flow
|
H, M
| |||
11/23/2020
|
RapidRona, Inc.
|
Home Collection Kit
|
N/A
| |||
11/23/2020
|
Gravity Diagnostics, LLC
|
Real-time RT-PCR, Home Collection, Screening, Saliva
|
H
| |||
11/17/2020
|
Lucira Health, Inc.
|
Prescription Home Testing
|
W
| |||
11/06/2020
|
GenScript USA Inc.
|
Total Neutralizing Antibodies, Blocking ELISA
|
H
| |||
10/28/2020
|
Quansys Biosciences, Inc.
|
IgG, CLIA
|
H
| |||
10/28/2020
|
DNA Genotek Inc.
|
Saliva Collection Device
|
N/A
| |||
10/26/2020
|
Agena Bioscience, Inc.
|
RT-PCR, chip array and MALDI-TOF Mass Spec.
|
H
| |||
10/23/2020
|
Celltrion USA, Inc.
|
Magnetic Force-assisted Electrochemical Sandwich Immunoassay (MESIA)
|
H, M
| |||
10/20/2020
|
binx health, Inc.
|
Home Collection Kit
|
N/A
| |||
10/15/2020
|
Clinical Enterprise, Inc.
|
Home Collection Kit
|
N/A
| |||
10/14/2020
|
DNA Genotek Inc.
|
Saliva Collection Device
|
N/A
| |||
10/14/2020
|
LumiraDx UK Ltd.
|
RT, qSTAR amplification
|
H
| |||
10/09/2020
|
Abbott Laboratories Inc.
|
IgM, CMIA
|
H, M
| |||
10/08/2020
|
Access Bio, Inc.
|
Lateral Flow, Visual Read
|
H, M, W
| |||
10/08/2020
|
Beckman Coulter, Inc.
|
IgM, CLIA
|
H, M
| |||
10/08/2020
|
Spectrum Solutions LLC
|
Saliva Collection Device
|
N/A
| |||
10/07/2020
|
GenMark Diagnostics, Inc.
|
RT-PCR and electro-chemical detection, Multi-analyte
|
H, M
| |||
10/06/2020
|
University of California, Los Angeles (UCLA)
|
RT-PCR and Sequencing
|
H
| |||
10/06/2020
|
ZEUS Scientific, Inc.
|
IgG, ELISA
|
H, M
| |||
10/05/2020
|
Season Biomaterials, Inc.
|
RT-LAMP
|
H
| |||
10/02/2020
|
Quidel Corporation
|
Lateral Flow, Fluore-scence, Instrument Read, Multi-Analyte
|
H, M, W
| |||
10/02/2020
|
Thermo Fisher Scientific
|
Total Antibody, ELISA
|
H, M
| |||
10/02/2020
|
BioFire Diagnostics, LLC
|
RT, Nested multiplex PCR, Multi-Analyte
|
H, M, W
| |||
10/01/2020
|
Beckman Coulter, Inc.
|
One-step immuno-enzymatic ("sandwich") assay, IL-6
|
H, M
| |||
10/01/2020
|
UMass Memorial Medical Center
|
Real-time RT-PCR
|
H
| |||
10/01/2020
|
Tempus Labs, Inc.
|
Real-time RT-PCR
|
H
| |||
09/30/2020
|
Aeon Global Health
|
Real-time RT-PCR
|
H
| |||
09/30/2020
|
Alimetrix, Inc.
|
RT-PCR, Microarray Hybridization
|
H
| |||
09/29/2020
|
CENTOGENE US, LLC
|
Real-time RT-PCR, Screening
|
H
| |||
09/29/2020
|
Akron Children’s Hospital
|
Real-time RT-PCR
|
H
| |||
09/29/2020
|
National Jewish Health
|
RT-PCR and MALDI-TOF Mass Spec.
|
H
| |||
09/29/2020
|
DiaSorin, Inc.
|
IgM, Indirect CLIA
|
H, M
| |||
09/29/2020
|
NanoEntek America, Inc.
|
Total Antibody, FIA
|
H, M
| |||
09/29/2020
|
Nirmidas Biotech, Inc.
|
IgM and IgG, Lateral Flow
|
H, M
| |||
09/25/2020
|
Genetrack Biolabs, Inc.
|
Real-time RT-PCR
|
H
| |||
09/25/2020
|
Quotient Suisse SA
|
Total Antibody, photometric immuno-assay
|
H
| |||
09/24/2020
|
Cepheid
|
Real-time RT-PCR, Multi-analyte
|
H, M, W
| |||
09/23/2020
|
Jiangsu Well Biotech Co., Ltd.
|
IgM and IgG, Lateral Flow
|
H, M
| |||
09/23/2020
|
Clear Labs, Inc.
|
RT-PCR and Sequencing
|
H
| |||
09/22/2020
|
Quadrant Biosciences Inc.
|
Real-time RT-PCR, Saliva
|
H
| |||
09/22/2020
|
Vela Operations Singapore Pte. Ltd.
|
Real-time RT-PCR
|
H
| |||
09/21/2020
|
KimForest Enterprise Co., Ltd.
|
Real-time RT-PCR
|
H
| |||
09/18/2020
|
GK Pharmaceuticals Contract Manufacturing Operations
|
Real-time RT-PCR
|
H
| |||
09/16/2020
|
Visby Medical, Inc.
|
RT-PCR
|
H, M
| |||
09/14/2020
|
Roche Molecular Systems, Inc.
|
Real-time RT-PCR, Multi-analyte
|
H, M, W
| |||
09/14/2020
|
Shenzhen New Industries Biomedical Engineering Co., Ltd.
|
IgM and IgG, CLIA
|
H, M
| |||
09/09/2020
|
BioCheck, Inc.
|
IgM, CLIA
|
H, M
| |||
09/09/2020
|
BioCheck, Inc.
|
IgG, CLIA
|
H, M
| |||
09/09/2020
|
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
|
Real-time RT-PCR
|
H
| |||
09/08/2020
|
Verily Life Sciences
|
Real-time RT-PCR, Pooling
|
H
| |||
09/04/2020
|
BillionToOne, Inc.
|
Sequencing
|
H
| |||
09/03/2020
|
Sugentech, Inc.
|
IgG, Lateral Flow
|
H, M
| |||
09/03/2020
|
Roche Molecular Systems, Inc.
|
Real-time RT-PCR, Multi-analyte
|
H, M
| |||
09/02/2020
|
Real-time RT-PCR
|
Molecular
|
H
| |||
09/01/2020
|
Detectachem Inc.
|
RT-LAMP
|
H
| |||
09/01/2020
|
OPTOLANE Technologies, Inc.
|
Real-time RT-PCR
|
H
| |||
08/31/2020
|
TBG Biotechnology Corp.
|
IgM and IgG, Lateral Flow
|
H, M
| |||
08/31/2020
|
University of Arizona Genetics Core for Clinical Services
|
Total Antibody, ELISA
|
H
| |||
08/31/2020
|
T2 Biosystems, Inc.
|
RT, amplification, T2 Magnetic resonance
|
H
| |||
08/31/2020
|
MiraDx
|
Real-time RT-PCR
|
H
| |||
08/31/2020
|
Mammoth Biosciences, Inc.
|
RT-LAMP, CRISPR
|
H
| |||
08/31/2020
|
BayCare Laboratories, LLC
|
Real-time RT-PCR, Pooling
|
H
| |||
08/31/2020
|
Color Genomics, Inc.
|
Home Collection Kit
| ||||
08/28/2020
|
Patients Choice Laboratories, LLC
|
Real-time RT-PCR
|
H
| |||
08/28/2020
|
DxTerity Diagnostics, Inc.
|
Real-time RT-PCR, Home Collection, Screening, Saliva
|
H
| |||
08/26/2020
|
Cuur Diagnostics
|
Real-time RT-PCR
|
H
| |||
08/26/2020
|
Abbott Diagnostics Scarborough, Inc.
|
Antigen Lateral Flow, Visual Read
|
H, M, W
| |||
08/25/2020
|
Biocan Diagnostics Inc.
|
IgM and IgG, Lateral Flow
|
H, M
| |||
08/25/2020
|
Fluidigm Corporation
|
Real-time RT-PCR, Saliva
|
H
| |||
08/25/2020
|
QDx Pathology Services
|
Real-time RT-PCR, Home Collection
|
H
| |||
08/21/2020
|
Guardant Health, Inc.
|
Sequencing
|
H
| |||
08/21/2020
|
DxTerity Diagnostics, Inc.
|
Real-time RT-PCR, Saliva
|
H
| |||
08/21/2020
|
Texas Department of State Health Services, Laboratory Services Section
|
Real-time RT-PCR
|
H
| |||
08/18/2020
|
LumiraDx UK Ltd.
|
Antigen Microfluidic Immuno-fluorescence Assay, Instrument Read
|
H, M, W
| |||
08/17/2020
|
BioCheck, Inc.
|
IgM and IgG, CLIA
|
H, M
| |||
08/17/2020
|
Diazyme Laboratories, Inc.
|
IgM, CLIA
|
H, M
| |||
08/17/2020
|
ZhuHai Sinochips Bioscience Co., Ltd.
|
Real-time RT-PCR
|
H
| |||
08/15/2020
|
Yale School of Public Health, Department of Epidemiology of Microbial Diseases
|
Real-time RT-PCR, Saliva
|
H
| |||
08/13/2020
|
Pro-Lab Diagnostics
|
RT, Isothermal amplification
|
H
| |||
08/11/2020
|
Biomeme, Inc.
|
Real-time RT-PCR
|
H
| |||
08/11/2020
|
LumiraDx UK Ltd.
|
RT, non-isothermal nucleic acid amplification qSTAR
|
H
| |||
08/10/2020
|
Solaris Diagnostics
|
Real-time RT-PCR
|
H
| |||
08/10/2020
|
Alpha Genomix Laboratories
|
Real-time RT-PCR
|
H
| |||
08/07/2020
|
George Washington University Public Health Laboratory
|
Real-time RT-PCR
|
H
| |||
08/06/2020
|
bioMérieux SA
|
IgM, ELFA
|
H, M
| |||
08/06/2020
|
bioMérieux SA
|
IgG, ELFA
|
H, M
| |||
08/06/2020
|
Helix OpCo LLC (dba Helix)
|
Sequencing
|
H
| |||
08/05/2020
|
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
|
Total Antibody, ELISA
|
H
| |||
08/05/2020
|
Vela Operations Singapore Pte Ltd.
|
Real-time RT-PCR
|
H
| |||
08/03/2020
|
ISPM Labs, LLC dba Capstone Healthcare
|
Real-time RT-PCR
|
H
| |||
08/03/2020
|
Wren Laboratories LLC
|
Real-time RT-PCR
|
H
| |||
08/03/2020
|
Ethos Laboratories
|
RT-PCR and MALDI-TOF Mass Spec.
|
H
| |||
08/03/2020
|
Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute
|
Real-time RT-PCR
|
H
| |||
08/03/2020
|
Poplar Healthcare
|
TMA, chemiluminescent, Pooling
|
H
| |||
07/31/2020
|
Siemens Healthcare Diagnostics Inc.
|
IgG, Semi-quantitative
|
H, M
| |||
07/31/2020
|
Siemens Healthcare Diagnostics Inc.
|
IgG, Semi-quantitative
|
H, M
| |||
07/31/2020
|
Xiamen Zeesan Biotech Co., Ltd.
|
Real-time RT-PCR
|
H
| |||
07/31/2020
|
University of California San Diego Health
|
Real-time RT-PCR, Pooling
|
H
| |||
07/30/2020
|
Clinical Reference Laboratory, Inc.
|
Real-time RT-PCR, Home Collection, Saliva
|
H
| |||
07/27/2020
|
Eli Lilly and Company
|
Real-time RT-PCR
|
H
| |||
07/27/2020
|
Sandia National Laboratories
|
Real-time RT-PCR
|
H
| |||
07/24/2020
|
Xiamen Biotime Biotechnology Co., Ltd.
|
IgM and IgG, Lateral Flow
|
H, M
| |||
07/24/2020
|
Access Bio, Inc.
|
IgM and IgG, Lateral Flow
|
H, M
| |||
07/24/2020
|
Jiangsu CoWin Biotech Co., Ltd.
|
Real-time RT-PCR
|
H
| |||
07/23/2020
|
Helix OpCo LLC (dba Helix)
|
Real-time RT-PCR
|
H
| |||
07/21/2020
|
DiaCarta, Inc.
|
Real-time RT-PCR
|
H
| |||
07/17/2020
|
Megna Health, Inc.
|
IgM and IgG, Lateral Flow
|
H, M
| |||
07/17/2020
|
Access Genetics, LLC
|
Real-time RT-PCR
|
H
| |||
07/16/2020
|
Boston Heart Diagnostics
|
Real-time RT-PCR
|
H
| |||
07/16/2020
|
Luminex Corporation
|
IgG, FMIA
|
H
| |||
07/15/2020
|
Quest Diagnostics Infectious Disease, Inc.
|
Real-time RT-PCR, Home Collection
|
H
| |||
07/15/2020
|
Quest Diagnostics Infectious Disease, Inc.
|
Real-time RT-PCR, Home Collection
|
H
| |||
07/15/2020
|
Quest Diagnostics Infectious Disease, Inc.
|
TMA, chemiluminescent, Home Collection
|
H
| |||
07/13/2020
|
Salofa Oy
|
IgM and IgG, Lateral Flow
|
H, M
| |||
07/13/2020
|
KogeneBiotech Co., Ltd.
|
Real-time RT-PCR
|
H
| |||
07/13/2020
|
Trax Management Services Inc.
|
Real-time RT-PCR
|
H
| |||
07/13/2020
|
Compass Laboratory Services, LLC
|
Real-time RT-PCR, Home Collection
|
H
| |||
07/10/2020
|
Boston Medical Center
|
Real-time RT-PCR
|
H
| |||
07/10/2020
|
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd
|
Total Antibody, Lateral Flow
|
H, M
| |||
07/09/2020
|
UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin
|
RT-LAMP
|
H
| |||
07/09/2020
|
BioSewoom, Inc.
|
Real-time RT-PCR
|
H
| |||
07/08/2020
|
Diazyme Laboratories, Inc.
|
IgG, CLIA
|
H, M
| |||
07/08/2020
|
Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard
|
Real-time RT-PCR
|
H
| |||
07/07/2020
|
Enzo Life Sciences, Inc.
|
Real-time RT-PCR
|
H
| |||
07/07/2020
|
Access Bio, Inc.
|
Real-time RT-PCR
|
H
| |||
07/07/2020
|
Gene By Gene
|
Real-time RT-PCR
|
H
| |||
07/06/2020
|
Assure Tech. (Hangzhou Co., Ltd)
|
IgM and IgG, Lateral Flow
|
H, M
| |||
07/06/2020
|
Laboratorio Clinico Toledo
|
Real-time RT-PCR
|
H
| |||
07/02/2020
|
Becton, Dickinson and Company (BD)
|
Antigen Chromato-graphic Digital Immuno-assay, Instrument Read
|
H, M, W
| |||
07/02/2020
|
Centers for Disease Control and Prevention (CDC)
|
Real-time RT-PCR, Multi-analyte
|
H
| |||
07/01/2020
|
CENTOGENE US, LLC
|
Real-time RT-PCR
|
H
| |||
06/30/2020
|
InBios International, Inc.
|
IgM, ELISA
|
H
| |||
06/30/2020
|
Psomagen, Inc.
|
Real-time RT-PCR
|
H
| |||
06/30/2020
|
TNS Co., Ltd (Bio TNS)
|
RT-PCR
|
H
| |||
06/30/2020
|
The Kroger Co.
|
Home Collection Kit
| ||||
06/29/2020
|
LifeHope Labs
|
Real-time RT-PCR
|
H
| |||
06/29/2020
|
Acupath Laboratories, Inc.
|
Real-time RT-PCR
|
H
| |||
06/26/2020
|
Beckman Coulter, Inc.
|
IgG , CLIA
|
H, M
| |||
06/26/2020
|
Inform Diagnostics, Inc.
|
Real-time RT-PCR
|
H
| |||
06/25/2020
|
Diagnostic Solutions Laboratory, LLC
|
Real-time RT-PCR
|
H
| |||
06/25/2020
|
PreciGenome LLC
|
RT-digital droplet PCR
|
H
| |||
06/25/2020
|
PlexBio Co., Ltd.
|
RT-PCR
|
H
| |||
06/24/2020
|
University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory
|
Real-time RT-PCR
|
H
| |||
06/23/2020
|
HealthQuest Esoterics
|
Real-time RT-PCR
|
H
| |||
06/23/2020
|
University of Alabama at Birmingham Fungal Reference Lab
|
Real-time RT-PCR
|
H
| |||
06/23/2020
|
Gencurix, Inc.
|
Real-time RT-PCR
|
H
| |||
06/23/2020
|
Babson Diagnostics, Inc.
|
IgG , CLIA
|
H
| |||
06/19/2020
|
Hangzhou Laihe Biotech Co., Ltd.
|
IgM and IgG Lateral Flow
|
H, M
| |||
06/18/2020
|
Biohit Healthcare (Hefei) Co. Ltd.
|
IgM and IgG Lateral Flow
|
H, M
| |||
06/18/2020
|
Jiangsu Bioperfectus Technologies Co., Ltd.
|
Real-time RT-PCR
|
H
| |||
06/18/2020
|
3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd.
|
Real-time RT-PCR
|
H
| |||
06/17/2020
|
The Ohio State University Wexner Medical Center
|
Real-time RT-PCR
|
H
| |||
06/17/2020
|
Omnipath-ology Solutions Medical Corporation
|
Real-time RT-PCR
|
H
| |||
06/15/2020
|
Applied BioCode, Inc.
|
RT-PCR
|
H
| |||
06/15/2020
|
Emory Medical Laboratories
|
Serology IgG
|
H
| |||
06/13/2020
|
Kaiser Permanente Mid-Atlantic States
|
Real-time RT-PCR, Home Collection, Screening
|
H
| |||
06/12/2020
|
RTA Laboratories Biological Products Pharma-ceutical and Machinery Industry
|
Real-time RT-PCR
|
H
| |||
06/10/2020
|
InBios International, Inc.
|
Serology IgG
|
H
| |||
06/10/2020
|
Tide Laboratories, LLC
|
Real-time RT-PCR
|
H
| |||
06/10/2020
|
TBG Biotechnology Corp.
|
Real-time RT-PCR
|
H
| |||
06/10/2020
|
Cue Health Inc.
|
RT, Isothermal amplification
|
H, W, M
| |||
06/09/2020
|
Illumina, Inc.
|
Sequencing
|
H
| |||
06/09/2020
|
ChromaCode Inc.
|
Real-time RT-PCR
|
H
| |||
06/08/2020
|
Siemens Healthcare Diagnostics Inc.
|
Total Antibody
|
H, M
| |||
06/08/2020
|
Euroimmun US Inc.
|
Real-time RT-PCR
|
H
| |||
06/05/2020
|
Genetron Health (Beijing) Co., Ltd.
|
Real-time RT-PCR
|
H
| |||
06/04/2020
|
Vibrant America Clinical Labs
|
Serology IgM and IgG
|
H
| |||
06/04/2020
|
Phosphorus Diagnostics LLC
|
Real-time RT-PCR, Home Collection, Saliva
|
H
| |||
06/04/2020
|
Hangzhou Biotest Biotech Co., Ltd.
|
Serology IgM and IgG
|
H
| |||
06/02/2020
|
Roche Diagnostics
|
Immuno-assay IL-6
|
H, M
| |||
06/01/2020
|
Gravity Diagnostics, LLC
|
Real-time RT-PCR, Home Collection
|
H
| |||
05/29/2020
|
Healgen Scientific LLC
|
Serology IgM and IgG
|
H, M
| |||
05/29/2020
|
Siemens Healthcare Diagnostics Inc.
|
Total Antibody
|
H, M
| |||
05/29/2020
|
Siemens Healthcare Diagnostics Inc.
|
Total Antibody
|
H, M
| |||
05/28/2020
|
PrivaPath Diagnostics, Inc.
|
TMA, chemiluminescent, Home Collection
|
H
| |||
05/22/2020
|
dba SpectronRx
|
Real-time RT-PCR
|
H
| |||
05/22/2020
|
Exact Sciences Laboratories
|
Real-time RT-PCR, Home Collection
|
H
| |||
05/21/2020
|
BioCore Co., Ltd.
|
Real-time RT-PCR
|
H
| |||
05/21/2020
|
SolGent Co., Ltd.
|
Real-time RT-PCR
|
H
| |||
05/21/2020
|
Seasun Biomaterials, Inc.
|
RT-LAMP
|
H
| |||
05/21/2020
|
P23 Labs, LLC.
|
Real-time RT-PCR, Home Collection, Saliva
|
H
| |||
05/18/2020
|
Quidel Corporation
|
Real-time RT-PCR
|
H
| |||
05/18/2020
|
Color Genomics, Inc.
|
RT, LAMP, Home Collection
|
H
| |||
05/15/2020
|
Everlywell, Inc.
|
Home Collection Kit
|
N/A
| |||
05/15/2020
|
Fulgent Therapeutics, LLC
|
Real-time RT-PCR, Home Collection
|
H
| |||
05/15/2020
|
Assurance Scientific Laboratories
|
Real-time RT-PCR, Home Collection
|
H
| |||
05/14/2020
|
Hologic, Inc.
|
TMA, chemiluminescent
|
H
| |||
05/14/2020
|
GeneMatrix, Inc.
|
Real-time RT-PCR
|
H
| |||
05/13/2020
|
Applied DNA Sciences, Inc.
|
Real-time RT-PCR
|
H
| |||
05/11/2020
|
1drop Inc.
|
Real-time RT-PCR
|
H
| |||
05/11/2020
|
Abbott Molecular Inc.
|
Real-time RT-PCR
|
H, M
| |||
05/08/2020
|
Quidel Corporation
|
Antigen Lateral Flow, Fluore-scence, Instrument Read
|
H, M, W
| |||
05/08/2020
|
Gnomegen LLC
|
Real-time RT-PCR
|
H
| |||
05/07/2020
|
Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics - Rutgers University
|
Real-time RT-PCR, Home Collection, Saliva
|
H
| |||
05/07/2020
|
Zymo Research Corporation
|
Real-time RT-PCR
|
H
| |||
05/06/2020
|
OPTI Medical Systems, Inc.
|
Real-time RT-PCR
|
H
| |||
05/06/2020
|
Sherlock BioSciences, Inc.
|
RT-LAMP, CRISPR
|
H
| |||
05/06/2020
|
BioMérieux SA
|
Real-time RT-PCR
|
H
| |||
05/05/2020
|
Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company)
|
Real-time RT-PCR
|
H
| |||
05/04/2020
|
EUROIMMUN US Inc.
|
Serology IgG
|
H
| |||
05/04/2020
|
Sansure BioTech Inc.
|
Real-time RT-PCR
|
H
| |||
05/02/2020
|
Roche Diagnostics
|
Serology Antibody
|
H, M
| |||
05/01/2020
|
Bio-Rad Laboratories, Inc.
|
RT-droplet PCR
|
H
| |||
05/01/2020
|
BioFire Diagnostics, LLC
|
RT, Nested multiplex PCR, Multi-analyte
|
H, M
| |||
04/30/2020
|
Wadsworth Center, New York State Department of Health
|
Serology Total Antibody
|
H
| |||
04/29/2020
|
LabGenomics Co., Ltd.
|
Real-time RT-PCR
|
H
| |||
04/29/2020
|
Rheonix, Inc.
|
RT-PCR
|
H
| |||
04/29/2020
|
Bio-Rad Laboratories
|
Serology Total Antibody
|
H
| |||
04/27/2020
|
Seasun Biomaterials
|
Real-time RT-PCR
|
H
| |||
04/26/2020
|
Abbott Laboratories Inc.
|
Serology IgG only
|
H, M
| |||
04/24/2020
|
DiaSorin Inc.
|
Serology IgG only
|
H, M
| |||
04/24/2020
|
Ortho-Clinical Diagnostics, Inc.
|
Serology IgG only
|
H, M
| |||
04/24/2020
|
Autobio Diagnostics Co. Ltd.
|
Serology IgM and IgG
|
H, M
| |||
04/23/2020
|
SD Biosensor, Inc.
|
Real-time RT-PCR
|
H
| |||
04/22/2020
|
altona Diagnostics GmbH
|
Real-time RT-PCR
|
H
| |||
04/21/2020
|
Seegene, Inc.
|
Real-time RT-PCR
|
H
| |||
04/20/2020
|
Trax Management Services Inc.
|
Real-time RT-PCR
|
H
| |||
04/18/2020
|
OSANG Healthcare
|
Real-time RT-PCR
|
H
| |||
04/17/2020
|
Fosun Pharma USA Inc.
|
Real-time RT-PCR
|
H
| |||
04/16/2020
|
KorvaLabs Inc.
|
Real-time RT-PCR
|
H
| |||
04/16/2020
|
GenoSensor, LLC
|
Real-time RT-PCR
|
H
| |||
04/15/2020
|
Maccura Biotechnology (USA) LLC
|
Real-time RT-PCR
|
H
| |||
04/15/2020
|
Mount Sinai Laboratory
|
Serology IgG
|
H
| |||
04/14/2020
|
Ortho Clinical Diagnostics, Inc.
|
Serology Total Antibody
|
H, M
| |||
04/10/2020
|
Atila BioSystems, Inc.
|
RT, Isothermal amplification
|
H
| |||
04/08/2020
|
DiaCarta, Inc.
|
Real-time RT-PCR
|
H
| |||
04/08/2020
|
Becton, Dickinson & Company
|
Real-time RT-PCR
|
H, M
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04/07/2020
|
InBios International, Inc.
|
Real-time RT-PCR
|
H
| |||
04/06/2020
|
Gnomegen LLC
|
Real-time RT-digital PCR
|
H
| |||
04/03/2020
|
Co-Diagnostics, Inc.
|
RT-PCR, CoPrimer technology
|
H
| |||
04/03/2020
|
ScienCell Research Laboratories
|
Real-time RT-PCR
|
H
| |||
04/03/2020
|
Luminex Corporation
|
RT-PCR
|
H, M
| |||
04/02/2020
|
Becton, Dickinson & Company (BD)
|
Real-time RT-PCR
|
H, M
| |||
04/01/2020
|
Ipsum Diagnostics, LLC
|
Real-time RT-PCR
|
H
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04/01/2020
|
Cellex Inc.
|
Serology IgM and IgG
|
H, M
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03/30/2020
|
QIAGEN GmbH
|
Real-time RT-PCR, Multi-analyte
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H, M
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03/30/2020
|
NeuMoDx Molecular, Inc.
|
RT-PCR
|
H, M
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03/27/2020
|
Abbott Diagnostics Scarborough, Inc.
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RT, Isothermal amplification
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H, M, W
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03/27/2020
|
Luminex Molecular Diagnostics, Inc.
|
RT-PCR
|
H
| |||
03/26/2020
|
BGI Genomics Co. Ltd.
|
Real-time RT-PCR
|
H
| |||
03/25/2020
|
Avellino Lab USA, Inc.
|
Real-time RT-PCR
|
H
| |||
03/24/2020
|
PerkinElmer, Inc.
|
Real-time RT-PCR
|
H
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03/23/2020
|
Mesa Biotech Inc.
|
RT and amplification
|
H, M, W
| |||
03/23/2020
|
BioFire Defense, LLC
|
RT, Nested multiplex PCR
|
H, M
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03/20/2020
|
Cepheid
|
Real-time RT-PCR
|
H, M, W
| |||
03/20/2020
|
Primerdesign Ltd.
|
Real-time RT-PCR
|
H
|